Z-2074-2017Class II

Access BR Monitor, Part No. 387620

Name: Z-2074-2017 Access BR Monitor, Part No. 387620
Creator: Beckman Coulter Inc.
Published: 2017-04-13
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2017-04-13 / Terminated / root cause: labeling and UDI

FDA source

Beckman Coulter Inc. began a recall of Access BR Monitor, Part No. 387620 on 2017-04-13. FDA classified it as Class II and gives the reason as "Following biases observed in the results of the French National Quality Controls, Beckman Coulter has been informed that a study completed by the French Competent Authority Agence nationale de scurit du Medicament et...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2074-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-13
Posted: 2017-05-12
Terminated: 2018-06-04
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access BR Monitor, Part No. 387620
Product code: MOI System, Test, Immunological, Antigen, Tumor
Reason for recall: Following biases observed in the results of the French National Quality Controls, Beckman Coulter has been informed that a study completed by the French Competent Authority Agence nationale de scurit du Medicament et des produits de sant (ANSM) showed diagnosed cancer patients in non-remission of their metastatic disease, may have results below the upper reference limit (URL) of 31.3 U/mL as stated in the Access BR Monitor instructions for use (IFU).
Root cause tag: labeling and UDI
FDA root cause: Other
Action: An urgent Medical Device Recall letter dated 4/13/17 was sent to customers following biases observed in the results of the French National Quality Controls, Beckman Coulter has been informed that a study completed by the French Competent Authority Agence nationale de scurit du Medicament et des produits de sant (ANSM) showed diagnosed cancer patients in non-remission of their metastatic disease, may have results below the upper reference limit (URL) of 31.3 U/mL as stated in the Access BR Monitor instructions for use (IFU). Customers are informed of the impact and the actions to be taken. Customers with any questions regarding the notice are instructed to contact Customer Technical Support Center: From our website: http://www.beckmancoulter.com By phone: call 1-800-854-3633 in the United States and Canada. Outside the United States and Canada, contact your local Beckman Coulter representative.
Quantity in commerce: 45,278 units total (2,419 units in US)
Distribution: Affected geographies: Algeria, Australia, Austria, Bangladesh, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Ecuador, Egypt, El Salvador, France, Georgia, Germany, Ghana, Gibraltar, Greece, Guam, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Libya, Lithuania, Malaysia, Mayotte, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Venezuela, Vietnam, Zimbabwe
Product codes and lots: 623913, 625701, 628771, 630349, 633070 and All Future Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2074-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2074-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-24	2017-05-12

Product code MOI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)